Chapter 450

450.02(3)(a) (a) Relating to the manufacture of drugs and the distribution and dispensing of prescription drugs.

450.02(3)(b) (b) Establishing security standards for pharmacies.

450.02(3)(c) (c) Relating to the manufacture, distribution and dispensing of hypodermic syringes, needles and other objects used, intended for use or designed for use in injecting a drug.

450.02(3)(d) (d) Necessary for the administration and enforcement of this chapter and ch. 961.

450.02(3)(e) (e) Establishing minimum standards for the practice of pharmacy.

450.02(3)(f) (f) Establishing procedures for identifying pharmacists and pharmacy technicians impaired by alcohol or other drugs or physical or mental disability or disease and for assisting those pharmacists and pharmacy technicians in obtaining treatment.

450.02(3m) (3m) 

450.02(3m)(a) (a) The board or its designee may grant a variance to a requirement of this chapter or to a rule promulgated by the board if all of the following are true:

450.02(3m)(a)1. 1. The board or its designee determines that a natural or man-made disaster or emergency exists or has occurred.

450.02(3m)(a)2. 2. A pharmacist has requested the variance.

450.02(3m)(a)3. 3. The board or its designee determines that the variance is necessary to protect the public health, safety, or welfare.

450.02(3m)(am) (am) If a member of the board disagrees with a decision made by a designee under par. (a) or sub. (3r), the board chairperson shall call a meeting of the board as soon as practicable to review the decision. The board may affirm or modify the designee’s decision.

450.02(3m)(b) (b) A variance granted under par. (a) shall be for a stated term not to exceed 90 days, except that the board or its designee may extend the variance upon request by a pharmacist if it determines that an extension is necessary to protect the public health, safety, or welfare.

450.02(3r) (3r) 

450.02(3r)(a) (a) The board or its designee may authorize a pilot program, and may grant a waiver or variance in connection with the pilot program from any rule promulgated by the board, if all of the following are true:

450.02(3r)(a)1. 1. The pilot program is related to the practice of pharmacy or prescription verification.

450.02(3r)(a)2. 2. The board or its designee determines that the pilot program will improve the safety, quality, or efficiency of the practice of pharmacy in this state.

450.02(3r)(b) (b) The board or its designee may not authorize a pilot program under par. (a) that lasts longer than 3 years.

450.02(4) (4) The board may not promulgate a rule which does any of the following:

450.02(4)(a) (a) Limits to a pharmacist the authority to sell or in any way interferes with the sale of nonnarcotic nonprescription drugs that are prepackaged for consumer use and labeled in compliance with all applicable state and federal laws.

450.02(4)(b) (b) Interprets s. 448.03 (2) (e) to expand the therapeutic alternate drug selection powers of a pharmacist beyond those specified in s. 450.01 (16) (h).

450.02(5) (5) The board may promulgate rules governing pharmacies that are operated as remote dispensing sites. Rules promulgated under this subsection may exempt pharmacies operated as remote dispensing sites from requirements governing pharmacies that are not operated as remote dispensing sites.

450.02 History History: 1985 a. 146; 1987 a. 65; 1995 a. 448; 1997 a. 68; 1997 a. 237 s. 727m; 2005 a. 270; 2015 a. 55, 290, 313; 2021 a. 25, 100, 101.

450.02 Cross-reference Cross-reference: See also Phar, Wis. adm. code.

450.03 450.03 Pharmacist; licensure.

450.03(1) (1) No person may engage in the practice of pharmacy or use the title “pharmacist” or sell, give away or barter drugs unless the person is licensed as a pharmacist by the board. This subsection does not apply to:

450.03(1)(a) (a) The offer to sell or sale of contraceptive articles, as defined under s. 450.155 (1) (a), by a registered nurse licensed under s. 441.06.

450.03(1)(b) (b) The sale of any nonprescription drug product, in an original unbroken package, which complies with 21 USC 301 to 392.

450.03(1)(c) (c) The sale of pesticides which comply with ss. 94.67 to 94.71.

450.03(1)(d) (d) The delivery of complimentary samples of drug products or devices to a practitioner by a manufacturer or its agent acting in the usual course of business.

450.03(1)(e) (e) Any person lawfully practicing within the scope of a license, permit, registration, certificate, or certification granted to practice as a pharmacy technician under s. 450.068, to provide home medical oxygen under s. 450.076, to practice professional or practical nursing or nurse-midwifery under ch. 441, to practice dentistry, dental therapy, or dental hygiene or as an expanded function dental auxiliary under ch. 447, to practice medicine and surgery under ch. 448, to practice optometry under ch. 449, to practice naturopathic medicine under ch. 466, or to practice veterinary medicine under ch. 89, or as otherwise provided by statute.

450.03(1)(f) (f) A person who has successfully completed his or her second year in, and is enrolled at, an accredited school of pharmacy and whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and administering vaccines or drugs as authorized under s. 450.035.

450.03(1)(fm) (fm) A person who is enrolled at an accredited school of pharmacy and whose practice of pharmacy is limited to administering vaccines or drugs as authorized under s. 450.035.

450.03(1)(g) (g) A person who has applied for a license under s. 450.05 whose practice of pharmacy is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and administering vaccines or drugs as authorized under s. 450.035 during the period before which the board takes final action on the person’s application.

450.03(1)(gm) (gm) A person who has applied for a registration under s. 450.068 and whose practice as a pharmacy technician is limited to performing duties under the direct supervision of a person licensed as a pharmacist by the board and during the period before which the board takes final action on the person’s application.

450.03(1)(h) (h) The provision of services by a health care provider under s. 257.03.

450.03(1)(i) (i) Any person, other than a pharmacy technician, who is providing services as directed, supervised, and inspected by a pharmacist who has the power to direct, decide, and oversee the implementation of the services rendered, subject to any rules promulgated by the board and subject to s. 450.035 (2m).

450.03(1)(j) (j) A person who dispenses, distributes, or sells dialysate drugs or devices necessary for providing home peritoneal kidney dialysis to a patient with end-stage renal disease if all of the following apply:

450.03(1)(j)1. 1. The person is licensed under s. 450.07 or 450.071, or is an agent of a person licensed under s. 450.07 or 450.071.

450.03(1)(j)2. 2. The person lawfully holds the dialysate drugs or devices.

450.03(1)(j)3. 3. The dialysate drugs or devices are held and delivered in their original, sealed packaging from the manufacturing facility.

450.03(1)(j)4. 4. The dialysate drugs or devices are delivered only pursuant to a prescription order issued by a licensed physician and only if an order from a licensed pharmacy is transmitted to the person.

450.03(1)(j)5. 5. The dialysate drugs or devices are delivered to one of the following:

450.03(1)(j)5.a. a. A patient with end-stage renal disease or the patient’s designee, for the patient to self-administer the dialysis therapy.

450.03(1)(j)5.b. b. A health care provider or institution, for administration or delivery of the dialysis therapy to a patient with end-stage renal disease.

450.03(1)(j)6. 6. If required by federal law, the dialysate drugs or devices are approved or cleared by the federal food and drug administration.

450.03(1)(k) (k) A person who sells, gives away, or barters hemp, as defined in s. 94.55 (1), or takes any of the actions described in s. 450.01 (16) (a) to (k) in relation to hemp.

450.03(1)(L) (L) A person who is providing services as directed, supervised, and inspected by a person described in par. (e) in any of the following settings:

450.03(1)(L)1. 1. A narcotic treatment service for opiate addiction, as defined in s. 51.4224 (1) (a).

450.03(1)(L)2. 2. A free and charitable clinic.

450.03(2) (2) Except as provided in s. 450.10, the board shall issue a license as a pharmacist to any person who does all of the following:

450.03(2)(a) (a) Has received a professional degree from a pharmacy program approved by the board.

450.03(2)(b) (b) Has completed an internship in the practice of pharmacy or has practical experience acquired in another state that is comparable to that included in an internship and that is approved and verified by the board or by the agency that is the equivalent of the board in the state in which the practical experience was acquired.

450.03(2)(c) (c) Passes the examination under s. 450.04.

450.03(2)(d) (d) Pays the fee specified in s. 440.05 (1).

450.03 History History: 1985 a. 146; 1987 a. 264; 1991 a. 39; 2001 a. 16; 2005 a. 96; 2009 a. 42; 2013 a. 114 ss. 25, 27, 28; 2015 a. 3, 55; 2017 a. 293, 366; 2019 a. 13, 68; 2021 a. 3, 100, 101, 130; 2021 a. 238 s. 45; 2021 a. 254; 2023 a. 87.

450.03 Cross-reference Cross-reference: See also chs. Phar 2 and 17, Wis. adm. code.

450.033 450.033 Services delegated by physician. A pharmacist may perform any patient care service delegated to the pharmacist by a physician, as defined in s. 448.01 (5).

450.033 History History: 2013 a. 294.

450.035 450.035 Administration of drug products and devices; vaccines.

450.035(1g) (1g) In this section, “drug product or device” does not include a vaccine.

450.035(1r) (1r) A pharmacist may not administer by injection a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A pharmacist who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under s. 450.02 (2g) (b). The pharmacist or his or her agent shall also, after the pharmacist administers a prescribed drug product or device under this subsection, notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner.

450.035(1t) (1t) A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) may not administer a prescribed drug product or device unless he or she has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) may administer a prescribed drug product or device under this subsection only under the direct supervision of a pharmacist who has successfully completed a course of study and training in administration technique conducted by a course provider approved by the Accreditation Council for Pharmacy Education or the board. A person engaged in the practice of pharmacy under s. 450.03 (1) (f) or (g) who administers a prescribed drug product or device under this subsection shall comply with the requirements and procedures established in rules promulgated by the board under s. 450.02 (2g) (b). The person or his or her agent shall also, after the person administers a prescribed drug product or device under this subsection, notify the prescribing practitioner or enter the information in a patient record system shared by the prescribing practitioner.

450.035(2) (2) A pharmacist may not administer a vaccine unless he or she has successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in vaccination storage, protocols, administration technique, emergency procedures, and record keeping and has satisfied the requirements specified in sub. (2t). Except as provided under sub. (2c), a pharmacist may not administer a vaccine under this subsection to a person who is under the age of 6.

450.035(2c) (2c) A pharmacist may administer a vaccine under sub. (2) to a person who is under the age of 6 if all of the following apply:

450.035(2c)(a) (a) The vaccine is administered pursuant to a prescription order issued within the 29 days immediately preceding the day on which the vaccine is administered.

450.035(2c)(b) (b) The pharmacist has successfully completed a course of instruction approved by the Accreditation Council for Pharmacy Education or the board that includes the administration of vaccines to children under the age of 6.

450.035(2g) (2g) 

450.035(2g)(a) (a) A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine unless he or she acts under the direct supervision of a health care provider authorized to administer vaccines and he or she has successfully completed 12 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in vaccination storage, protocols, administration technique, emergency procedures, and record keeping. If the supervising health care provider under this paragraph is a pharmacist, a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine unless the supervising pharmacist has successfully completed a course of study and training specified in sub. (2) and has satisfied the requirements specified in sub. (2t).

450.035(2g)(b) (b) A person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may not administer a vaccine under this subsection to a person who is under the age of 6.

450.035(2h) (2h) 

450.035(2h)(a) (a) A pharmacy technician may not administer a vaccine unless all of the following are satisfied:

450.035(2h)(a)1. 1. The pharmacy technician has successfully completed at least 2 hours in a course of study and training, approved by the Accreditation Council for Pharmacy Education or the board, in hands-on injection technique and the recognition and treatment of emergency reactions to vaccines.

450.035(2h)(a)2. 2. The pharmacy technician acts under the direct supervision of a pharmacist and the supervising pharmacist has successfully completed a course of study and training specified in sub. (2) and has satisfied the requirements specified in sub. (2t).

450.035(2h)(a)3. 3. The pharmacy technician holds a current certification in basic life support or cardiopulmonary resuscitation.

450.035(2h)(a)4. 4. The pharmacy technician holds a certified pharmacy technician certification from either the Pharmacy Technician Certification Board, or its successor organization, or the National Healthcareer Association, or its successor organization.

450.035(2h)(b) (b) A pharmacy technician may not administer a vaccine under this subsection to a person who is under the age of 6.

450.035(2i) (2i) 

450.035(2i)(a) (a) Subject to subs. (2), (2g), and (2h), a pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may administer without a prescription order any vaccine listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention.

450.035(2i)(b) (b) Subject to subs. (2), (2g), and (2h), a pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) may initiate and administer any vaccine not listed in the current immunization schedules recommended by the federal advisory committee on immunization practices and published by the federal centers for disease control and prevention if the vaccine is administered pursuant to a prescription order, vaccination protocol, or standing order.

450.035(2k) (2k) A person authorized to administer a vaccine under this section may administer by injection epinephrine and diphenhydramine to a person experiencing an adverse reaction to a vaccine.

450.035(2m) (2m) Except as provided in sub. (1t), (2g), (2h), or (2k), a pharmacist may not delegate to any person any administration of a prescribed drug product or device or vaccine under sub. (1r) or (2).

450.035(2t) (2t) A pharmacist may not administer a vaccine under sub. (2) or supervise a person administering a vaccine under sub. (2g) or (2h) unless the pharmacist satisfies each of the following:

450.035(2t)(a) (a) The pharmacist has in effect liability insurance that covers the pharmacist and a person who administers a vaccine under sub. (2g) or (2h) against loss, expense and liability resulting from errors, omissions or neglect in the administration of vaccines in an amount that is not less than $1,000,000 for each occurrence and $2,000,000 for all occurrences in any one policy year.

450.035(2t)(b) (b) The pharmacist maintains proof that he or she satisfies the requirement specified in par. (a) and, upon request, provides copies of such proof to the department or the board.

450.035(3) (3) A pharmacist, a pharmacy technician, or a person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who successfully completes a course of study and training specified in sub. (1r), (1t), (2), (2g), or (2h), or holds a certification under sub. (2h), shall maintain proof of completion or holding the certification and, upon request, provide copies of such proof to the department or the board.

450.035(4) (4) A pharmacist, pharmacy technician, or person engaged in the practice of pharmacy under s. 450.03 (1) (f), (fm), or (g) who administers a vaccine to a person under this section shall update, or cause a pharmacy to update, the Wisconsin Immunization Registry established by the department of health services within 7 days of administering the vaccine.

450.035 History History: 1997 a. 68; 1997 a. 237 s. 727m; 2003 a. 181; 2011 a. 32; 2013 a. 124; 2015 a. 290; 2017 a. 42; 2019 a. 24; 2021 a. 3, 100.

450.04 450.04 Examinations.